Description
This position is responsible for monitoring and tracking patients in clinical studies and pilots at Align Technology and ensuring that the studies are conducted according to protocol. Studies may also include treatment outcome collection programs with private practice doctors and/or universities. The process includes interaction and communication with clinical sites, study participants, universities, and treatment coordinators related to case specific issues and status.Roles:
- Monitor and track patients in study sites and treatment outcome collection programs
- Ensure adequate documentation and proper implementation of written protocols
- Assist in writing and developing clinical protocols, data tracking forms, informed consent documents, and clinical report forms. Secure approvals from regulatory and/or legal as needed for the program
- Provide technical assistance to study sites regarding the conduct of clinical research
Track data report forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites - Ensure that milestone payments are made according to protocol and budget timeline
- Comply with all regulatory and safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources
Requirements:
- Bachelor of Science, or equivalent experience (MS preferred)
- 5-6 years of experience as a Clinical Research Associate
- Experienced in desiging and running pre-market and post-market clinical studies for medical device companies
To find out more about Real please visit www.realstaffing.com